“The impact of traumatic brain injuries is felt within each branch of the service and throughout the Department of Defense, and were even considered the ‘signature wound’ from recent conflicts,” said Lt. Col. Kara Schmid, Project Manager for the Neurotrauma and Psychological Health Project Management Office for the U.S. Army Medical Materiel Development Activity. “Finding solutions for the diagnosis and evaluation of mild TBI has been a top priority for over a decade now. Obtaining FDA authorization for the first objective blood-based biomarkers of mild TBI is a huge success for the TBI community. This assay will provide a remarkable capability for the way we evaluate and care for our service members with TBI.”

Currently, the CT scan is routinely used to assist physicians in the evaluation of TBI. However, the use of CT scans is highly variable especially in the face of significant trauma with minimal symptoms. Lacking an approved biomarker to guide decision making, the default for physicians was to obtain a CT scan. More than 90 percent of patients presenting to the emergency department with mild TBI or concussion, have a negative CT scan.


“Brain biomarkers will change the practice of emergency care for mild TBI and will greatly assist a large number of patients. The impact will be improved medical care by reducing radiation exposure to the patient and improving efficiency in the emergency department,” stated Andy Jagoda, MD, Professor and Chair in the Department of Emergency Medicine at the Icahn School of Medicine at Mount Sinai.

The FDA granting of the De Novo request for Banyan BTI also creates a classification regulation for devices of this type and permits this diagnostic test to serve as a predicate device. The FDA granting was supported by a prospective multi-center pivotal study. The study called ALERT-TBI, enrolled 2,011 patients at 24 independent clinical sites in the United States and European Union and compared the test's results to head CT scans of patients presenting to emergency departments with suspected head injury. The study showed that Banyan BTI achieved high sensitivity and high NPV (negative predictive value) for ruling out the need for a head CT scan and provides objective data for healthcare providers to aid in the evaluation of patients with suspected TBI. The company is engaged in additional studies to determine if the biomarkers have applications in monitoring recovery after injury as well as their application in other degenerative conditions of the brain.

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